PregnancyNCT05035160
UCLA Perinatal Biospecimen Repository
An observational study of Pregnancy and High-Risk Pregnancy, run by Yalda Afshar, MD, PhD at 1 site in United States.
Trial summary
The purpose of this investigator-initiated prospective observational cohort study is to establish the new UCLA Perinatal Biospecimen Repository (Perinatal Repository) for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology. Read more about this study
- Who is it for?
- Ages 1 minute and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, High-Risk Pregnancy
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2021to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Ages Eligible for Study: Child, Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Study Population: Any UCLA Health patient that is at risk for perinatal pathology. Estimated Enrollment: 1000 participants.
Who may be able to join
- Pregnant and postpartum birthing persons aged 18 and over with perinatal pathology;
- Healthy pregnant and postpartum birthing persons;
- Healthy non-pregnant birthing persons (healthy volunteers).
Who cannot join
- Pregnant and postpartum birthing person unwilling to give written informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Afshar Lab, Department of Obstetrics & Gynecology, UCLA
Los Angeles, California, 90095
Yalda Afshar, MD, PhD, (805) 338-5593, YAfshar@mednet.ucla.edu
Jenny Lester, MPH, 323-428-2338, jlester@mednet.ucla.edu
About this study
The purpose of this investigator-initiated prospective observational cohort study is to establish the new UCLA Perinatal Biospecimen Repository (Perinatal Repository) for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology. The secure and shared high-quality resource of clinical data and biological specimens (Repository Materials), across pregnancy pathology related to research protocols at the Afshar's Lab will be created. Core variables of interest include clinical characteristics and relevant biological samples. Intention to collect perinatal data is aiding the efficiency and effectiveness of de-identified biorepository for pregnancy-at-risk outcome research.
The primary aims of the project are:
- To design the Case Report Forms (CRFs) for the clinical and biospecimen data.
- To create and update the project-specific policies, agreements, and Standard Operating Procedures (SOPs).
- To develop the data management system to assure personal health information de-identification, data integrity, participants welfare, and protocol compliance.
- To develop and implement a quality management system for the Repository.
- To collect and record in the Repository protocol-related clinical information.
- To organize a consistent system to bank high-quality biospecimens while protecting participant-donor safety and privacy.
- To establish the policies and procedures for Repository Materials dissemination and research collaboration.
- To analyze the scientific results of the Repository creation. The secondary aim of the study is to provide a mechanism to store and share for research purposes the de-identified biospecimen and information about participants at risk for adverse pregnancy outcomes.
Read the detailed description
Duration of the project - 5 years. The approximate number of participants - 1000. The number of visits - from one to 6. Duration of the subject's participation in the study - from 1 day to 12 months. Follow-up period: from enrollment to postpartum visit. Core variables of interest comprise the birthing person's/ fetus'/ neonate's clinical characteristics and relevant biological samples: maternal blood, cord blood, plasma, serum, urine, breastmilk, placenta, umbilical cord, amniotic fluid, the product of conception (POC), and cell lines. Collection and retaining of the biospecimens will be performed by the study team across perinatal pathology cases at the UCLA Health Medical Centers for up to 15 years.
Biospecimens will be collected prospectively to the Perinatal Repository. Clinical data will be linked to the biospecimens.
Participation in the Repository Protocol can be offered by the PI/ designee for the outpatients and inpatients. Eligibility criteria will be checked during the baseline visit. The informed consent form should be signed at enrolment, following which baseline medical history will be collected. Procedures and assessments will be performed according to the routine standard at UCLA Health, and are documented as available (with the exception of Informed Consent).
Enrolment/ Baseline Visit: After consenting, the birthing person will be asked to donate blood (maternal blood) or/ and urine specimen to the Repository. Trained research team personnel will collect the biospecimens per standard operating procedures. The study protocol provides for the collection of blood samples as a procedure combined with routine blood sampling for clinical laboratory testing.
For research purposes, it is intended to collect a small additional amount of the venous maternal blood - less than 10 mL per procedure. The blood will not be drawn for research more often than twice in a single week. Blood draws will be performed as follow: Red Top Tube (Serology tube) - at least 10 mL and Lavender Top Tube (EDTA tube) - at least 10 mL. Blood samples will be collected for whole blood, plasma, and serum banking.
Collection of the cord blood after delivery will be performed once in the same order. The research Protocol does not involve collecting any specimens of the vital neonates, such as venous blood or urine.
Follow-up Visits: For pregnant birthing persons, biospecimens donation during follow-up visits is optional, based on the PI decision. Repository Material will be collected by the research team during follow-up research visits (each once per pregnancy trimester):
- st Trimester Visit (from conception to 12 weeks): medical history, pregnancy and fetus status, AE, biobank specimens: blood and urine.
- nd Trimester Visit (from week 13 to week 27): medical history, pregnancy and fetus status, AE, biobank specimens: blood and urine.
- rd Trimester Visit: (from week 28 until birth): medical history, pregnancy and fetus status, biobank specimens: blood and urine.
Delivery/ End of Pregnancy Visit: Medical history, pregnancy status, pregnancy outcome, neonatal/ fetus status, neonatal/ fetus outcome, AE, biobank specimens: maternal blood, cord blood (UC blood), maternal urine, placenta, umbilical cord, amniotic fluid.
The umbilical cord and placenta are temporary fetus organs. For the Repository collection, placenta, umbilical cord, and therefore, cord blood, will be obtained for the Repository purposes after childbirth.
In case of a miscarriage, abortion, or stillbirth, the participant will be asked to donate POC tissue to the Repository.
Postpartum Visit: Medical history, pregnancy outcome, neonatal status, neonatal outcome, AE, biobank specimens: maternal blood, maternal urine, breastmilk.
For non-pregnant healthy volunteers, participation in the project is limited to the one-time biospecimens donation and granting access to their medical records.
After collecting the necessary clinical information, all personal identifiable information of the participant will be encoded. The PI will retain access to the codes.
In case of an MTA arrangement and providing access to the Repository to the third party, only de-identified participants' information and de-identified biospecimens can be shared.
- Conditions
- Pregnancy, High-Risk Pregnancy
- Keywords
- Fetus, Obstetrics, Perinatal Care, Pregnancy, Specimen Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pregnant and postpartum birthing persons with perinatal pathology. | |
| Group 2 | Healthy pregnant and postpartum birthing persons. | |
| Group 3 | Healthy non-pregnant persons (healthy volunteers). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants of the Perinatal Repository
To establish the Perinatal Repository for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology
Measured: From July 30, 2021, to December 31, 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start30 Jul 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Yalda Afshar, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor-investigator, Yalda Afshar, MD, PhD, University of California, Los Angeles
- Investigators
- Yalda Afshar, MD, PhD, MD. PHD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035160
- Sponsor's protocol ID
- IRB#21-001018
- Status last verified
- Dec 2025
- First submitted
- 25 Aug 2021
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Study Organization: The Perinatal Repository will be created and maintained by the investigator, initiated this project - Dr. Yalda Afshar, and designee - the Afshar's Lab. personnel. 2. Request of the Repository Biospecimens and/ or Data by the Investigators or other Entities: The original task of the Perinatal Repository creation is to provide Afshar's Lab resources for ongoing and future clinical and non-clinical research. 3. Access to the Repository Material may be granted to: * the PIs from the UCLA; * the PIs from other universities; * the institutions/ entities engaged in research in the field of health science and biotechnology. 4. The PI, external to the Afshar's Lab, may contact the chief of the Repository for preliminary information. The adequacy of requests to obtain data and/or biospecimens is reviewed by the Committee on the terms and conditions established by the UCLA Perinatal Biospecimen Repository Advisory Committee Policy.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCLA Perinatal Biospecimen Repository
- ClinicalTrials.gov ID
- NCT05035160
- Acronym / sponsor ID
- IRB#21-001018
- Conditions
- Pregnancy, High-Risk Pregnancy
- Keywords
- Fetus, Obstetrics, Perinatal Care, Pregnancy, Specimen Collection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yalda Afshar, MD, PhDUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigator-initiated prospective observational cohort study is to establish the new UCLA Perinatal Biospecimen Repository (Perinatal Repository) for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology. The secure and shared high-quality resource of clinical data and biological specimens (Repository Materials), across pregnancy pathology related to research protocols at the Afshar's Lab will be created. Core variables of interest include clinical characteristics and relevant biological samples. Intention to collect perinatal data is aiding the efficiency and effectiveness of de-identified biorepository for pregnancy-at-risk outcome research.
The primary aims of the project are:
- To design the Case Report Forms (CRFs) for the clinical and biospecimen data.
- To create and update the project-specific policies, agreements, and Standard Operating Procedures (SOPs).
- To develop the data management system to assure personal health information de-identification, data integrity, participants welfare, and protocol compliance.
- To develop and implement a quality management system for the Repository.
- To collect and record in the Repository protocol-related clinical information.
- To organize a consistent system to bank high-quality biospecimens while protecting participant-donor safety and privacy.
- To establish the policies and procedures for Repository Materials dissemination and research collaboration.
- To analyze the scientific results of the Repository creation. The secondary aim of the study is to provide a mechanism to store and share for research purposes the de-identified biospecimen and information about participants at risk for adverse pregnancy outcomes.
Detailed description
Duration of the project - 5 years. The approximate number of participants - 1000. The number of visits - from one to 6. Duration of the subject's participation in the study - from 1 day to 12 months. Follow-up period: from enrollment to postpartum visit. Core variables of interest comprise the birthing person's/ fetus'/ neonate's clinical characteristics and relevant biological samples: maternal blood, cord blood, plasma, serum, urine, breastmilk, placenta, umbilical cord, amniotic fluid, the product of conception (POC), and cell lines. Collection and retaining of the biospecimens will be performed by the study team across perinatal pathology cases at the UCLA Health Medical Centers for up to 15 years.
Biospecimens will be collected prospectively to the Perinatal Repository. Clinical data will be linked to the biospecimens.
Participation in the Repository Protocol can be offered by the PI/ designee for the outpatients and inpatients. Eligibility criteria will be checked during the baseline visit. The informed consent form should be signed at enrolment, following which baseline medical history will be collected. Procedures and assessments will be performed according to the routine standard at UCLA Health, and are documented as available (with the exception of Informed Consent).
Enrolment/ Baseline Visit: After consenting, the birthing person will be asked to donate blood (maternal blood) or/ and urine specimen to the Repository. Trained research team personnel will collect the biospecimens per standard operating procedures. The study protocol provides for the collection of blood samples as a procedure combined with routine blood sampling for clinical laboratory testing.
For research purposes, it is intended to collect a small additional amount of the venous maternal blood - less than 10 mL per procedure. The blood will not be drawn for research more often than twice in a single week. Blood draws will be performed as follow: Red Top Tube (Serology tube) - at least 10 mL and Lavender Top Tube (EDTA tube) - at least 10 mL. Blood samples will be collected for whole blood, plasma, and serum banking.
Collection of the cord blood after delivery will be performed once in the same order. The research Protocol does not involve collecting any specimens of the vital neonates, such as venous blood or urine.
Follow-up Visits: For pregnant birthing persons, biospecimens donation during follow-up visits is optional, based on the PI decision. Repository Material will be collected by the research team during follow-up research visits (each once per pregnancy trimester):
- st Trimester Visit (from conception to 12 weeks): medical history, pregnancy and fetus status, AE, biobank specimens: blood and urine.
- nd Trimester Visit (from week 13 to week 27): medical history, pregnancy and fetus status, AE, biobank specimens: blood and urine.
- rd Trimester Visit: (from week 28 until birth): medical history, pregnancy and fetus status, biobank specimens: blood and urine.
Delivery/ End of Pregnancy Visit: Medical history, pregnancy status, pregnancy outcome, neonatal/ fetus status, neonatal/ fetus outcome, AE, biobank specimens: maternal blood, cord blood (UC blood), maternal urine, placenta, umbilical cord, amniotic fluid.
The umbilical cord and placenta are temporary fetus organs. For the Repository collection, placenta, umbilical cord, and therefore, cord blood, will be obtained for the Repository purposes after childbirth.
In case of a miscarriage, abortion, or stillbirth, the participant will be asked to donate POC tissue to the Repository.
Postpartum Visit: Medical history, pregnancy outcome, neonatal status, neonatal outcome, AE, biobank specimens: maternal blood, maternal urine, breastmilk.
For non-pregnant healthy volunteers, participation in the project is limited to the one-time biospecimens donation and granting access to their medical records.
After collecting the necessary clinical information, all personal identifiable information of the participant will be encoded. The PI will retain access to the codes.
In case of an MTA arrangement and providing access to the Repository to the third party, only de-identified participants' information and de-identified biospecimens can be shared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Pregnant and postpartum birthing persons with perinatal pathology. |
| Group 2 | – | –Healthy pregnant and postpartum birthing persons. |
| Group 3 | – | –Healthy non-pregnant persons (healthy volunteers). |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ages Eligible for Study: Child, Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Study Population: Any UCLA Health patient that is at risk for perinatal pathology. Estimated Enrollment: 1000 participants.
Key inclusion criteria (3 listed)
- Pregnant and postpartum birthing persons aged 18 and over with perinatal pathology;
- Healthy pregnant and postpartum birthing persons;
- Healthy non-pregnant birthing persons (healthy volunteers).
Key exclusion criteria (1 listed)
- Pregnant and postpartum birthing person unwilling to give written informed consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants of the Perinatal Repository
Time frame: From July 30, 2021, to December 31, 2028
To establish the Perinatal Repository for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes. 1. Study Organization: The Perinatal Repository will be created and maintained by the investigator, initiated this project - Dr. Yalda Afshar, and designee - the Afshar's Lab. personnel. 2. Request of the Repository Biospecimens and/ or Data by the Investigators or other Entities: The original task of the Perinatal Repository creation is to provide Afshar's Lab resources for ongoing and future clinical and non-clinical research. 3. Access to the Repository Material may be granted to: * the PIs from the UCLA; * the PIs from other universities; * the institutions/ entities engaged in research in the field of health science and biotechnology. 4. The PI, external to the Afshar's Lab, may contact the chief of the Repository for preliminary information. The adequacy of requests to obtain data and/or biospecimens is reviewed by the Committee on the terms and conditions established by the UCLA Perinatal Biospecimen Repository Advisory Committee Policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yalda Afshar, MD, PhD, MD. PHD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and High-Risk Pregnancy, run by Yalda Afshar, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yalda Afshar, MD. PhD ((805) 338-5593, yafshar@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants of the Perinatal Repository (time frame: From July 30, 2021, to December 31, 2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.